Hand Sanitizer

SPL v1

SPL

SPL Set ID b0f162fe-3bac-cc3c-e053-2995a90a271f

Route

TOPICAL

Published

Effective Date 2020-07-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Aloe Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Glycerin Water .alpha.-tocopherol Acetate, Dl-

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-08-01

Description

Ethyl Alcohol 70% v/v

Medication Information

Warnings and Precautions

Flammable. Keep away from heat or flame

For external use only.

Indications and Usage

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and Administration

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Description

Ethyl Alcohol 70% v/v

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a physician if skin irritation or rash develops.

Section 50567-7

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Section 51727-6

Water, Glycerin, Carbomer, Aloe, Tocopheryl Acetate

Section 51945-4

3785 mL NDC: 79097-020-28

Section 55105-1

Antiseptic

Section 55106-9

Ethyl Alcohol 70% v/v

Section 59845-8

place enough product in your palm to thoroughly cover your hands

rub hands together briskly until dry

children under 6 years of age should be supervised when using this product

Section 60561-8

Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

Structured Label Content

Indications and Usage (34067-9)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and Administration (34068-7)

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Warnings and Precautions (34071-1)

Flammable. Keep away from heat or flame

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a physician if skin irritation or rash develops.

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Section 51727-6 (51727-6)

Water, Glycerin, Carbomer, Aloe, Tocopheryl Acetate

Section 51945-4 (51945-4)

3785 mL NDC: 79097-020-28

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Ethyl Alcohol 70% v/v

Section 59845-8 (59845-8)

place enough product in your palm to thoroughly cover your hands

rub hands together briskly until dry

children under 6 years of age should be supervised when using this product

Section 60561-8 (60561-8)

Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

Advanced Ingredient Data

[{"name": "ALOE", "unii": "V5VD430YW9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A", "unii": "NX76LV5T8J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE, DL-", "unii": "WR1WPI7EW8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "34068-7": "Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.", "34071-1": "Flammable. Keep away from heat or flame For external use only.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a physician if skin irritation or rash develops.", "50567-7": "When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.", "51727-6": "Water, Glycerin, Carbomer, Aloe, Tocopheryl Acetate", "51945-4": "3785 mL NDC: 79097-020-28", "55105-1": "Antiseptic", "55106-9": "Ethyl Alcohol 70% v/v", "59845-8": "place enough product in your palm to thoroughly cover your hands rub hands together briskly until dry children under 6 years of age should be supervised when using this product", "60561-8": "Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:21.492687 · Updated: 2026-03-14T22:59:17.868516